Associate Quality Engineer

As an Associate Quality Engineer at MTF Biologics, you'll assist in defining and executing process validations and equipment qualifications. Your role will involve collaborating with departments like Quality Assurance, Research & Development, and Process Engineering, focusing on quality system implementation and compliance with FDA regulations. You'll also participate in developing specifications, conducting risk assessments, and coordinating testing projects with outside laboratories to ensure quality control throughout.

To qualify for the Associate Quality Engineer role at MTF Biologics, candidates should possess a Bachelor’s degree in a scientific discipline such as Biology or Chemistry, with 0-3 years of experience in quality assurance or FDA regulatory environments. Familiarity with statistical concepts for process capability analysis, strong communication skills, and knowledge of tools like Microsoft Office and statistical software such as Minitab are also essential.

The work environment for an Associate Quality Engineer at MTF Biologics is primarily an office setting with access to clean rooms. You'll be working in a laboratory environment that involves exposure to human tissue and various analytical and mechanical testing equipment. This role may require occasional travel, estimated at 10-15%, to coordinate special project testing with external consultants.

Associate Quality Engineers at MTF Biologics enjoy a comprehensive benefits package that includes four weeks of Paid Time Off (PTO), paid holidays, health, dental, and vision insurance. Additional perks include a 401K plan with company matching, short and long-term disability insurance, tuition reimbursement, and flexible spending accounts for healthcare and dependent care, among others.

MTF Biologics values employee growth and development. As an Associate Quality Engineer, you'll have opportunities to participate in projects that enhance your skills and knowledge in quality systems and regulatory compliance. With a supportive environment that encourages learning and professional advancement, you may also have the chance to pursue industry certifications such as ASQ-CQA or CQE, further enhancing your career trajectory.

To ensure compliance with quality standards, I focus on thorough documentation of processes, regular audits, and continuous feedback from team members. I also stay updated on relevant regulations and best practices, utilizing these insights to inform our quality assurance strategies and actively participate in training sessions.

In my previous roles, I approached data analysis by first defining key metrics and objectives. I utilized statistical software like Minitab to analyze process capability and identify trends. I also made it a point to work collaboratively with my team to interpret the results and convert them into actionable insights for quality improvements.

In my last position, I noticed a recurring issue with a specific product line that was leading to increased rework rates. I conducted a root cause analysis, identifying a gap in training for our production team. I proposed a refresher training and updated our SOPs, which effectively reduced errors and improved our overall quality metrics.

During my internship, I assisted in preparing documentation for FDA submissions and learned the importance of adhering to cGMP regulations. I regularly reviewed procedures and processes to ensure they met FDA guidelines, and I participated in internal audits to uphold compliance standards across our production lines.

I prioritize tasks by assessing deadlines, project importance, and resource availability. I often create a project tracker that outlines each task's urgency and complexity, allowing me to allocate time effectively while keeping communication lanes open with my team to adjust priorities as needed.

Teamwork is essential in quality assurance as it fosters diverse perspectives and collaborative problem-solving. I believe that communicating openly with colleagues from different departments can lead to more effective identification and resolution of quality issues, ultimately leading to enhanced product safety and efficacy.

When writing SOPs, I ensure to begin with a clear understanding of the processes involved. I engage with stakeholders to gather input and draft a document that is both comprehensive and user-friendly. After drafting, I solicit feedback to make necessary revisions, followed by a review process to ensure compliance and clarity.

I am familiar with several statistical methods, including control charts for monitoring process stability, process capability analysis for assessing the ability of a process to produce output within specification limits, and hypothesis testing for quality comparisons. I regularly apply these techniques to analyze data and drive improvements.

I stay updated on industry practices and regulations by regularly reading relevant journals, attending webinars, and engaging with professional organizations. Networking with peers in the quality engineering field also provides valuable insights and keeps me informed about emerging trends and changes in compliance requirements.

A successful Associate Quality Engineer possesses strong analytical skills, attention to detail, and effective communication abilities. They should also be proactive in problem-solving, adaptable in the face of changes, and committed to continuous learning to keep up with evolving industry standards and practices.